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The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive theRapy (TRICOLOR)

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ClinicalTrials.gov Identifier: NCT03722524
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Servier Russia

Brief Summary:

The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension: opportunity for effective BP control with cOmbined antihypertensive therapy.

The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice.

Type of program: Multicenter, observational, non-controlled, open-label program.

Investigators: Cardiologists and outpatient (primary care) physicians (general practitioners).

Number of patients: 1,300 hypertensive patients.


Condition or disease Intervention/treatment
Arterial Hypertension Drug: amlodipine / indapamide / perindopril arginine FDC

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Multinational Observational Uncontrolled Open Programme "The Use of TRIple Fixed-dose COmbination in the Treatment of arteriaL Hypertension: Opportunity for Effective BP Control With cOmbined Antihypertensive Therapy"
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with arterial hypertension Drug: amlodipine / indapamide / perindopril arginine FDC
CCB / diuretic / ACE inhibitor




Primary Outcome Measures :
  1. The effectiveness of triple FDC of amlodipine / indapamide / perindopril arginine in terms of BP control in hypertensive patients from the real clinical practice. [ Time Frame: 3 months ]
    • Office BP and pulse rate measurements


Secondary Outcome Measures :
  1. • The 24-hour BP profile on the top of FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice. [ Time Frame: 3 months ]
    • Ambulatory blood pressure monitoring (ABPM) (in those patients, in whom it is required, according to the decision of treating physician, based on his/her experience and established practice). The BP will be measured on the non-dominant arm. The measurements will be carried out every 15 minutes in the daytime from 7:00 to 23:00 and every 30 minutes in the nighttime from 23:00 to 7:00.

  2. • Tolerability of the triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice. [ Time Frame: 3 months ]
    • Assessment of the treatment tolerability by completion of the standard pharmacovigilance form.

  3. • Compliance with the treatment with triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients from the real clinical practice. [ Time Frame: 3 months ]
    • Assessment of the patient's compliance with the treatment will be carried out using the compliance questionnaire .



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with uncontrolled arterial hypertension who needs triple antihypertensive combinations in a single tablet
Criteria

Inclusion Criteria:

  • Age 18 to 79 years
  • Essential hypertension
  • Patient's consent to participate in the program
  • Doctor's decision to prescribe FDC of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program.

Exclusion Criteria:

  • Symptomatic, or secondary arterial hypertension
  • Office BP ≥ 180/110 mm Hg on treatment (at V0 visit)
  • History of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year
  • CHF of class III-IV NYHA
  • Type I diabetes or decompensated type 2 diabetes
  • Diseases with severe organ dysfunction (hepatic failure, renal failure, etc.)
  • Contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ACE inhibitors (including perindopril) and/or their fixed combination
  • Inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the BP self-monitoring.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722524


Contacts
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Contact: Yury Karpov, Prof +7 495 414 68 46 yuri_karpov@inbox.ru

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Sponsors and Collaborators
Servier Russia

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Responsible Party: Servier Russia
ClinicalTrials.gov Identifier: NCT03722524     History of Changes
Other Study ID Numbers: IC4-06593-057-RUS
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Perindopril
Indapamide
Indapamide, perindopril drug combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors